This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 A randomised controlled trial (RCT) of 77 patients with obesity and type 2 diabetes compared duodenal–jejunal bypass liner (DJBL) treatment in combination with dietary intervention (n=38) against dietary intervention alone (n=39) for 6 months. It reported that glycated haemoglobin (HbA1c) levels improved from 8% at baseline to 7% in the DJBL plus diet group, but remained at about 8% in the diet‑alone group at 6‑month follow‑up. The difference between the 2 groups was significant (p<0.05).
4.2 The RCT of 77 patients reported that, at 12‑month follow‑up (including 6 months after DJBL removal), fasting glucose levels had decreased from 11.0 mmol/litre to 9.0 mmol/litre in the DJBL plus diet group compared with 9.7 mmol/litre in the diet‑alone group. The difference between the 2 groups was not significant (p=0.41).
4.3 The RCT of 77 patients reported that, at 12‑month follow‑up (including 6 months after DJBL removal), fasting insulin levels remained the same in the DJBL plus diet group (15.0 mU/litre), and decreased in the diet‑alone group (from 17.0 mU/litre to 15.7 mU/litre). The difference between the 2 groups was not significant (p=0.73).
4.4 A case series of 22 patients with obesity and type 2 diabetes treated with a DJBL reported that improved glycaemic control (mean percentage decrease of −1.7±0.7% in HbA1c from a baseline level of 8.9±1.7%) continued for up to 6 months after device removal in 11 patients.
4.5 The RCT of 77 patients reported that, at 12‑month follow‑up, blood pressure had decreased from 147/92 mmHg to 130/82 mmHg in the DJBL plus diet group and from 152/90 mmHg to 140/85 mmHg in the diet‑alone group. The difference between the 2 groups was not significant (p=0.31 for systolic pressure and p=0.38 for diastolic pressure). At 12‑month follow‑up, total cholesterol levels were comparable with those at baseline and the difference between the 2 groups was not significant (4.4 mmol/litre in both groups; p=0.79).
4.6 The case series of 22 patients reported significant reductions in total cholesterol (mean decrease of −19.7±5.9 mg/dl from a baseline level of 201±37 mg/dl; p<0.01) and triglycerides (mean decrease of −44.8±17.4 mg/dl from a baseline level of 213±89 mg/dl; p<0.05) at last observation on or before device removal.
4.7 A case series of 81 patients reported improvement in insulin resistance, with a significant reduction in triglyceride/high density lipoprotein (HDL) ratio from 5.75 to 4.36 (p<0.001). Also, 43% of patients had a triglyceride/HDL ratio lower than 3.5, 6 months after DJBL implantation.
4.8 In the RCT of 77 patients, at 12‑month follow‑up, the daily insulin dose and use of sulfonylureas had decreased or the medication had been stopped in the DJBL plus diet group more often than in the diet‑alone group (p<0.05).
4.9 In the case series of 81 patients, the DJBL could not be implanted in 4% (3/81) of patients because they had a short duodenal bulb.
4.10 The specialist advisers listed key efficacy outcomes as reduced insulin resistance leading to improved glycaemic control; reduction in HbA1c, hypoglycaemic medication use, fasting insulin, C‑peptide and HOMA‑IR; and improvement in hypertension and quality of life, both in the short and long term (that is, after the device has been removed).